Zimmer Biomet Recalls Regenerex Patella Implants Due to Peg Shearing
Zimmer Biomet is recalling 8,154 Regenerex Series A Patella implants because the pegs may shear after surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a structural defect (pegs shearing) in a load-bearing medical device, which aligns with the rubric criteria for a Severe rating involving significant injury risk or structural defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling 8,154 units of the Regenerex Series A Patella implants. The affected models are 141355, 141356, 141357, and 141358, which correspond to 28mm, 31mm, 34mm, and 37mm sizes. These implants are used for non-cemented resurfaced 3-peg patella applications within the Vanguard Complete Knee System.
The recall was initiated because the pegs on the implants may shear post-operatively. This defect could compromise the stability of the knee implant after the surgical procedure.
The affected products were distributed nationwide in the United States and in Canada. Healthcare providers and patients who have received these specific implants should contact Zimmer Biomet for further instructions on how to proceed.
The recalled product
- Product
- Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 8,154
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots of Model #'s: 141355 141356 141357 141358
Distribution
Distributed nationwide across the United States.
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